A Phase 1, Open Label, Randomized, 2-Period, 2-Treatment, Crossover Study to Assess the Effect of Plazomicin on the Pharmacokinetics of Metformin in Healthy Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Achaogen, Inc.
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics of metformin in plasma
Study Overview
Brief Summary
This is a single-center, Phase 1, open label, randomized, two-sequence, two-period, crossover study to evaluate the drug-drug interaction potential between plazomicin and metformin in healthy subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Medically healthy, with no clinically significant medical history, physical examination findings, vital signs, or ECG findings
Exclusion Criteria
- •Estimated creatinine clearance <90 mL/min
- •Use of tobacco- or nicotine-containing products
- •History in the past 90 days of prior trauma to the outer or internal structures of the ear or tinnitus
- •History or family history of vestibular disorder, chronic vertigo (sensation of spinning), chronic dizziness
- •History of hearing loss or a family history of hearing loss, or a prior diagnosis of sensorineural hearing loss or Ménière's disease
Arms & Interventions
Sequence 1
In Period 1, subjects receive metformin alone; in Period 2, subjects receive metformin + plazomicin
Intervention: plazomicin (Drug)
Sequence 1
In Period 1, subjects receive metformin alone; in Period 2, subjects receive metformin + plazomicin
Intervention: metformin (Drug)
Sequence 2
In Period 1, subjects receive metformin + plazomicin; in Period 2, subjects receive metformin alone
Intervention: plazomicin (Drug)
Sequence 2
In Period 1, subjects receive metformin + plazomicin; in Period 2, subjects receive metformin alone
Intervention: metformin (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics of metformin in plasma
Time Frame: 9 days
Secondary Outcomes
- Incidence and severity of adverse events(15 days)
- Change from baseline in vital signs post dose (temperature, pulse, respiration, blood pressure)(8 days)
- Pharmacokinetics of plazomicin in plasma(9 days)
- Absolute values of and change from baseline in clinical laboratory values (hematology, serum chemistry, urine analysis)(9 days)
- Pharmacokinetics of metformin in urine(9 days)